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Study 13 of 427 for search of: | Canada, Newfoundland and Labrador |
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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00261352 |
This is a 24-week study to determine the lipid metabolic effects, safety, and tolerability of tesaglitazar compared with metformin and metformin in combination with fenofibrate in patients with type 2 diabetes and low high-density lipoprotein cholesterol (HDL-C). Improvement in dyslipidemia will be evaluated. The study comprises a 2-week enrollment period, 6-week run-in and a 24-week randomized, double blind, parallel group, multi-center, active controlled (metformin with or without fenofibrate) treatment period and a 3-week follow-up. From visit 2 (run-in), all patients will receive a standardized dose of statin (rosuvastatin)
Condition | Intervention | Phase |
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Type 2 Diabetes |
Drug: Tesaglitazar Drug: Metformin Drug: Fenofibrate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A 24-Week Randomised, Double-Blind, Parallel-Group, Multi-Centre, Active-Controlled (Metformin or Metformin Combined With Fenofibrate) Study to Evaluate the Lipid Metabolic Effects, Safety and Tolerability of Tesaglitazar Therapy in Patients With Type 2 Diabetes and Low HDL-Cholesterol on a Fixed Background Therapy With a Statin |
Estimated Enrollment: | 1000 |
Study Start Date: | March 2005 |
Study Completion Date: | February 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | AstraZeneca Galida Medical Science DIrector, MD | AstraZeneca |
Study ID Numbers: | D6160C00003, EudraCT No 2004-02550-56 |
Study First Received: | December 1, 2005 |
Last Updated: | March 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00261352 |
Health Authority: | Canada: Health Canada |
Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Procetofen |
Antimetabolites Hypoglycemic Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Antilipemic Agents Physiological Effects of Drugs Pharmacologic Actions |